Human Papillomavirus VirusesEPHaVINCT02895399
Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers
An observational study of Human Papillomavirus Viruses, run by Centre Hospitalier de Cayenne.
Trial summary
Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Viruses
- What is being tested?
- Cervico-Vaginal Smears analysis
- How many people
- 643 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women from 20 to 65 years living on the Maroni and the Oyapock rivers having already had sexual intercourse
Who may be able to join
- Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )
- Having already had sexual intercourse
- Having given after information , consent to the inclusion in the study
Who cannot join
- Age < 20 or age> 65 years
- Being pregnant more than 3 months
- Have had a hysterectomy
- Denial of participation
About this study
Official title: Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock
Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection.
Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.
- Conditions
- Human Papillomavirus Viruses
- Being tested
- Cervico-Vaginal Smears analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervico-Vaginal Smears analysisOther
Cervico-Vaginal Smears analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and distribution of Human Papillomaviruses genotypes
Measured: At the time of inclusion (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VirusesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 643 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895399
- Sponsor's protocol ID
- 30814
- Acronym
- EPHaVI
- Status last verified
- Sep 2016
- First submitted
- 5 Sep 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidémiologie de l'Infection à Human Papilloma Virus Chez Les Femmes Vivant Sur Les Fleuves Maroni et Oyapock
- ClinicalTrials.gov ID
- NCT02895399
- Acronym / sponsor ID
- EPHaVI / 30814
- Conditions
- Human Papillomavirus Viruses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 643 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have shown that populations living in remote villages in the interior of the territory have early sexual relations and that multiple sexual partnerships are frequent. Hence, the main objective of the study was to determine the prevalence of HPV in these areas, and the predictive factors and epidemiology of this viral infection.
Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65 years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to participate will be included after being informed of the study team schedule through radio address and key opinion leaders. The search for HPV and cytologic examinations will be performed for each woman. 2 samples will be taken from each woman: one sample will be sent to Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in Cayenne for sequencing and detection of E6 and E7 RNA which are associated with carcinogenesis. HPV infection will be defined by the detection of viral DNA using the GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping will use Mapinfo.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women from 20 to 65 years living on the Maroni and the Oyapock rivers having already had sexual intercourse
Key inclusion criteria (3 listed)
- Women aged from 20 to 65 living in a common Maroni rivers (Apatou , Grand Santi, Papaichton , Maripasoula and the Native American territory of Upper Maroni) and / or Oyapock ( Saint Georges, Camopi , Three Jumps )
- Having already had sexual intercourse
- Having given after information , consent to the inclusion in the study
Key exclusion criteria (4 listed)
- Age < 20 or age> 65 years
- Being pregnant more than 3 months
- Have had a hysterectomy
- Denial of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervico-Vaginal Smears analysisCervico-Vaginal Smears analysis | Other | – |
Primary outcome
Prevalence and distribution of Human Papillomaviruses genotypes
Time frame: At the time of inclusion (baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Viruses, run by Centre Hospitalier de Cayenne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and distribution of Human Papillomaviruses genotypes (time frame: At the time of inclusion (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.